Medical Devices
Health Canada's device licensing runs on a 4-class risk system, distinct from drug licensing — and it's not just the importer that needs a licence.
Get a Medical Devices RateHS 90
Instruments & apparatus chapter
4
Health Canada device risk classes (I–IV)
MDEL
Import licence — every class needs one
Dec 2026
Phase II licensing amendments take effect
Health Canada Medical Device Licensing
Medical devices run on a 4-class risk system distinct from drug licensing — and both the device and the importer can need separate licences
Class I devices need only the importer's Medical Device Establishment Licence (MDEL) with the import activity listed. Class II, III, and IV devices need that same importer MDEL, plus a Medical Device Licence (MDL) for the specific device itself, held by the manufacturer. This is a separate regime from the Drug Establishment Licence (DEL) used for pharmaceuticals — don't assume DEL coverage extends to devices.
Source: Health Canada, Regulatory requirements for importing medical devices; Medical Devices Regulations. Last verified July 2026.
Relevant HS Codes
| HS Code | Description | MFN | CPTPP | Note |
|---|---|---|---|---|
| 9018.11.10 | Electro-cardiographs | Free | Free | — |
| 9018.12 | Ultrasonic scanning apparatus | Free | Free | — |
| 9018.13 | Magnetic resonance imaging apparatus | Free | Free | — |
| 9018.14 | Scintigraphic apparatus | Free | Free | — |
| 9018.19.10 | Patient monitoring systems | Free | Free | — |
| 9018.19.90 | Other electro-diagnostic apparatus | Free | Free | — |
| 9018.20 | Ultra-violet or infra-red ray apparatus | Free | Free | — |
| 9018.31 | Syringes, with or without needles | Free | Free | — |
Source: https://www.cbsa-asfc.gc.ca/trade-commerce/tariff-tarif/2026/html/00/ch90-eng.html
Canadian Import Process
Classify the device
Confirm which of Health Canada's 4 risk classes (I–IV) the device falls into — this determines whether an MDL is required in addition to the importer's MDEL.
Confirm the importer's MDEL
Confirm the Canadian importer holds a valid MDEL with the import activity listed — required for every class, no exceptions.
Confirm MDL for Class II–IV
For Class II, III, or IV devices, confirm the manufacturer holds a valid Medical Device Licence for that specific device before booking.
CBSA examination
Goods clear against the commercial invoice, HS classification, and the MDEL/MDL references on file.
Customs release
Shipment released to the importer.
Worked example
200kg of patient monitoring systems, Singapore to Toronto
A 200kg shipment of patient monitoring systems (HS 9018.19.10) needs to move from SIN to YYZ. The fastest confirmed routing on that pair today is China Airlines through TPE, at 2-3 days (TPE freighter connection, limited to Mon/Thu departures).
Before booking, UAL confirms the Canadian importer's MDEL lists the import activity, and — because patient monitoring systems are typically Class II — confirms the manufacturer holds a valid MDL for that specific model.
HS 9018.19.10 clears Free at the standard MFN rate already, so no CPTPP claim changes the outcome here. On arrival, CBSA clears the shipment against the commercial invoice and the MDEL/MDL references on file.
Why ship medical devices through UAL
MDEL and MDL checked, not assumed
We confirm the importer's MDEL and, where the device class requires it, the manufacturer's MDL before booking — not a generic pharma-style checklist applied to a different regulatory regime.
Lithium battery handling where devices need it
Portable devices — defibrillators, patient monitors — often ship with lithium batteries installed. We classify and declare those correctly under the same PI967 framework used for consumer electronics.
Time-sensitive, handled that way
Medical device shipments are often tied to a facility's equipment installation schedule. We route via whichever carrier has the transit time that schedule actually needs.
DGR Note — Battery-Powered Medical Devices
Defibrillators, patient monitors, and other portable devices often ship with lithium batteries installed
Where a lithium-ion battery is installed in the device rather than shipped alone, PI967 (UN 3481, contained in equipment) applies — the same framework covered in depth on our lithium battery shipping guide, not a separate medical-device-specific rule.
Read the full lithium battery shipping guide →Source: IATA Dangerous Goods Regulations, PI967.
Frequently asked questions
No — they're separate Health Canada regimes. The DEL covers drugs, APIs, and biologics; the MDEL covers medical devices. Don't assume DEL coverage extends to a device shipment, and vice versa.
Medical Devices · 33 HS codes · CPTPP savings on 0 codes
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